PDP | Talent Acquisition Specialist | Life Science Engineering | CQV & Project Controls
JOB SUMMARY
We are seeking a skilled CQV Engineer to join our team, supporting the commissioning, qualification, and validation of automated filling lines within a regulated manufacturing environment (pharmaceutical, biotech, or similar).
You will play a pivotal role in ensuring project delivery, compliance with industry standards (GMP), and operational excellence.
MAIN RESPONSIBILITIES
Lead and execute CQV activities for automated filling lines, including commissioning, IQ/OQ/PQ qualification, and process validation.
Review and develop protocols, FAT/SAT documentation, and lifecycle qualification plans aligned with industry standards and client requirements.
Work collaboratively with project, engineering, and operations teams to ensure seamless system integration and startup.
Identify and resolve technical and compliance-related issues encountered during commissioning and validation.
Draft, review, and finalize all CQV documentation, including protocols (IQ, OQ, PQ), reports, change controls, deviations, risk assessments, and summary reports.
Ensure all documentation is prepared in strict compliance with GMP and GDP requirements, with clarity and accuracy for regulatory audits and inspections.
Maintain meticulous records and document management systems throughout the project lifecycle.
Collaborate with cross-functional teams to gather necessary data for validation documentation.
Liaise with equipment vendors, contractors, and clients to coordinate schedules, deliverables, and project updates.
Support the implementation of risk assessments, change controls, and deviation management within the CQV framework.
Train and mentor junior staff in CQV methodologies and Good Documentation Practices (GDP).
Stay up to date with regulatory guidance, emerging technologies, and industry trends affecting filling lines and related equipment.
EDUCATION/QUALIFICATIONS
Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Process, or related field).
Proven experience (5+ years) in Commissioning, Qualification, and Validation within the pharmaceutical or biotechnology sector; specific experience with filling lines is highly preferred.
Demonstrated excellence in documentation preparation and management for CQV processes.
In-depth knowledge of GMP regulations, industry standards, and validation practices.
Strong analytical, troubleshooting, and communication skills.
Fluency in English
Seniority level
: Mid-Senior level
Employment type
: Contract
Job function
: Engineering Services, Pharmaceutical Manufacturing, and Biotechnology Research
Location: Cork, County Cork, Ireland
Salary: €45,******-€50,******
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